US Marshalls Seize Caraco's Drug Products at Three Sites

On June 25, 2009, US Marshalls seized all drug products and ingredients at three facilities of Caraco Pharmaceutical Laboratories: Detroit, Farmington Hills, and Wixom, Michigan. The seizure followed a request from the US Food and Drug Administration, which cited the generic-drug company’s failure to meet current good manufacturing practices (CGMPs) requirements. FDA did not declare that the drug products manufactured by Caraco that are already on the market pose any risks to public safety.

Caraco Pharmaceutical Laboratories manufactures 33 drug products that, according to FDA, “may be affected” by the seizure. Of these products, FDA is stating that as a result of the seizure, there may be a shortage of choline magnesium trisalicylate oral tablets. The agency does not expect the seizure to result in a shortage of any other drug product because they are manufactured by other companies.

According to an FDA statement, the agency’s most recent inspection, completed in May 2009, found “unresolved violations of CGMP requirements. [The] seizure is intended to lead to major changes at Caraco’s facilities.”  The company is not permitted to distribute its drug products until FDA is assured that Caraco has fully met CGMP requirements.

According to a Caraco statement,

“The company believes that corrective actions have been made and continual improvements are in process. The FDA has only seized products manufactured in its Michigan facilities. Products distributed by Caraco that are manufactured outside of these facilities are not impacted. While we have not fully determined the impact of this action by the FDA on our financial condition, we believe that it may have a material adverse effect on our near term operations. We anticipate working with the FDA to resolve these concerns as effectively and expeditiously as possible.”

For the past year, Caraco has had FDA observations. The company’s Detroit facility received a

List of Inspectional Observations

and a subsequent

Warning Letter

resulting from a May–June 2008 inspection. On March 31, 2009, the company announced a

recall

of its heart medication Digoxin, USP, tablets (0.125 mg and 0.25 mg) because “they may differ in size and therefore could have more or less of the active ingredient digoxin.” On May 12, 2009, FDA issued a Form 483 letter to Caraco following its inspection of the company’s quality and production systems. Caraco Pharmaceutical Laboratories is a subsidiary of Sun Pharma (Mumbai).

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